Search / Trial NCT06617377

Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Sep 24, 2024

Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Prognosis Coma Cardiac Arrest Structural Mri Resting State Cognitive Motor Dissociation

Description

There is a major need for timely, reliable and generalizable methods to predict outcomes in anoxo-ischemic coma patients. Standard predictors of poor outcome after cardiac arrest (CA) include clinical, electrophysiological and serum biomarkers data. All have substantial limitations in terms of reliability and generalizability. By providing whole-brain structural and functional connectivity maps, or connectomes, advanced MRI techniques have precisely revealed the brain network damages induced by CA. Because these individualized connectomic profiles contains critical information about conscio...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Adult patients (male or female ≥ 18 years).
  • * Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset.
  • * Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in normothermia conditions.
  • * Written informed consent from patient's legal representative.
  • * Affiliation or beneficiary to the French social security system.
  • Exclusion Criteria:
  • * Brain death.
  • * Coma explained by other cause than CA.
  • * Likely poor neurological outcome based on early predictors, following ERC-ESCIM 2021 recommendations. In a comatose patient with GCS motor score ≤ 3 at ≥ 72 h from ROSC, in the absence of confounders, the identification of at least two of the following: bilaterally absent pupillary light and corneal reflexes at ≥ 72h, bilaterally absent N20 SSEP ≥ 24h; neuron-specific enolase (NSE) \> 60 μg/l at 48h and/or 72h, status myoclonus ≤72h.
  • * Decision of WLST previous to patient recruitment, based on early predictors of poor neurological outcome, age, co-morbidity, general organ function and patient's preferences.
  • * Life expectancy shorter than 6 months based on pre-morbid conditions.
  • * Former neurological functional disability (mRS \> 2 before CA).
  • * MRI contraindication: medical material not MRI compatible, claustrophobia
  • * Known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium
  • * Severe kidney failure defined as a KDIGO score \> 3 (glomerular filtration rate \< 30 ml/min/1.73 m2 or renal replacement therapy).
  • * Hemodynamic shock or severe respiratory failure precluding patient's transport and MRI scanning.
  • * Pregnancy or nursing woman.
  • * Patient under juridical protection.

About University Hospital, Toulouse

The University Hospital of Toulouse is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific inquiry with comprehensive clinical services. Its multidisciplinary team of healthcare professionals collaborates with renowned researchers to facilitate pioneering studies across various medical fields, aiming to enhance treatment options and improve patient outcomes. As a prominent institution in the region, the University Hospital of Toulouse is committed to fostering an environment of excellence in both education and research within the healthcare community.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0